FDA Adverse Event
Malfunction
Summary report: N
QUANTUM INTERSEGMENTAL TABLE
MDR report key: 24564302
·
Received March 10, 2026
Report
- Report Number
- 3007278668-2026-00001
- Event Type
- Malfunction
- Date Received
- March 10, 2026
- Manufacturer
- PIVOTAL HEALTH SOLUTIONS
- Product Code
- ISA
- Removal / Correction Number
- 97861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE HEATING FUNCTION WAS DISABLED.
Description of Event or Problem · 0
THE PRODUCT'S HEAT FUNCTION HAD MALFUNCTIONED. IT OCCURRED A NUMBER OF YEARS BEFORE BEING REPORTED SO THERE ARE NO DETAILS. HOWEVER OTHER REPORTS OF A SIMILAR INCIDENT INDICATED POTENTIAL SAFETY RISK SO REPORT IS SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617913 | QUANTUM INTERSEGMENTAL TABLE | QUANTUM | ISA | PIVOTAL HEALTH SOLUTIONS | AMQ401H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |